Senior Director of Quality and Regulatory Affairs

4 weeks ago


Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time

Job Summary

This role is responsible for leading the global design quality assurance, regulatory, and clinical affairs functions for Waters Clinical Business Unit. The ideal candidate will have extensive experience in regulatory affairs, particularly in medical devices and in-vitro diagnostics, and will be able to develop and implement global regulatory strategies.

Key Responsibilities

  • Lead the development and implementation of global regulatory strategies for Waters Clinical Business Unit.
  • Manage and grow the teams, providing direction and leadership, ensuring that company objectives and regulatory requirements are met in the most efficient manner possible.
  • Oversee the process of preparing product submissions and registrations to domestic and international regulatory bodies, managing the process from inception to approval and maintenance.
  • Manage and conduct Regulatory Affairs activities including those related to New Product Development, Change Management, Post Market, potential Adverse events.
  • Participate in due diligence and integration activities of acquisitions that have regulatory implications.
  • Lead and manage Clinical Design Quality Assurance, provide solution-based decision making, and drive continuous improvement.

Requirements

  • Minimum of an Advanced degree (PhD, in a Life Science, MBA or equivalent)
  • Proven extensive regulatory affairs experience with medical devices, IVD experience essential
  • Extensive and proven understanding of FDA and global regulations, including China, Europe (IVDR), India, and Brazil
  • Significant managerial experience, including across multiple locations
  • Good business acumen and good collaboration skills to meet business needs in partnership with other key stakeholders and functions

About Waters Corporation

Waters Corporation is the world's leading specialty measurement company, pioneering chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries.



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